Standing Tall (Yima Nkqo)

NCT04568460 | Active Not Recruiting Phase 2

• 1 other identifier: 2019P002671
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

The investigators propose the Standing Tall study, a prospective randomised study of strategy to optimize community-based ART initiation in South Africa. Investigators will work closely with community members to integrate community-based ART. One hundred participants will be enrolled and followed for a total of up to 6 months. Those in the intervention arm will be provided with the ST intervention which includes a behavioral component and access to ART. The intervention will be linked to a clinic through a "Nurse Initiated Management of ART."

Conditions

HIV

Outcome Measures

Primary Outcomes (4)

• ART Initiation

  ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.

  Three Months

• ART Initiation

  ART initiation will also be assessed via a point-of-care diagnostic detecting Tenofovir concentrations in participants.

  Three Months

• ART Initiation

  ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.

  Six months

• ART Initiation

  ART initiation will also be assessed via a point-of-care diagnostic detecting Tenofovir concentrations in participants.

  Six months

Secondary Outcomes (10)

• Viral Load Suppression

  Six Months

• Household Food Security

  Six Months

• Mental Health

  Six Months

• Substance Use

  Six Months

• Wellness

  Six Months

Study Arms (2)

Intervention Group Sessions

EXPERIMENTAL

Intervention group sessions will be delivered by lay health counselors. The sessions will reflect principles of co-learning, participatory design, and empowerment to promote engagement of young people in critical thinking and problem solving - including modeling, roleplaying, and interactive activities.

Other: Intervention Group Sessions

Standard of Care

NO INTERVENTION

This is the standard of care arm. Participants newly diagnosed with HIV will get a referral to the local primary health care setting of their choice for further management, including ART.

Interventions

Intervention Group Sessions OTHER

Participants will undergo a multi-session group intervention over the course of six months.

Also known as: Yima Nkqo

Intervention Group Sessions

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Complete an assessment of understanding
• Provide informed consent
• Are between ages 18-24
• Present to Tutu Tester vans in Cape Town OR East London DTHF clinics (Duncan Village Day Hospital, Empilweni Gompo Health Centre, Gompo C Clinic) and test HIV+
• Are ART-naïve
• Are English or isiXhosa speakers
• Reside in the Cape Town or East London metro area

You may not qualify if:

• Are pregnant (must be referred to antenatal clinic if living with HIV)
• Test positive for tuberculosis (must be referred to clinic for TB treatment prior to ART initiation)
• Are unable to understand the process of informed consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Desmond Tutu Health Foundation: collaborator
• University of Connecticut: collaborator
• Columbia University: collaborator
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of Washington: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Desmond Tutu Health Foundation

East London, Eastern Cape, South Africa

Location

Desmond Tutu Health Foundation

Cape Town, Western Cape, South Africa

Location

Related Publications (2)

• Bondarchuk CP, Lemon T, Medina-Marino A, Rousseau E, Sindelo S, Sibanda N, Butler LM, Bekker LG, Earnshaw VA, Katz IT. A Moderated Mediation Model of HIV-Related Anticipated Stigma and Social Capital on the Relationship Between Diagnosis During the COVID-19 Pandemic and Potentially Problematic Substance Use Among Young South Africans. Int J Behav Med. 2025 Nov 18. doi: 10.1007/s12529-025-10415-5. Online ahead of print.

  PMID: 41249762 DERIVED

• Nardell MF, Sindelo S, Rousseau E, Siko N, Fuzile P, Julies R, Bassett IV, Mellins CA, Bekker LG, Butler LM, Katz IT. Development of "Yima Nkqo," a community-based, peer group intervention to support treatment initiation for young adults with HIV in South Africa. PLoS One. 2023 Jun 15;18(6):e0280895. doi: 10.1371/journal.pone.0280895. eCollection 2023.

  PMID: 37319250 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: September 29, 2020
• Study Start: November 25, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ZA (2)